|
Device | SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | BOSTON SCIENTIFIC SCIMED, INC. One Scimed Place Maple Grove, MN 55311 |
PMA Number | P970061 |
Date Received | 12/22/1997 |
Decision Date | 07/16/1998 |
Withdrawal Date
|
07/17/2007 |
Product Code |
MAF |
Docket Number | 99M-1980 |
Notice Date | 06/28/1999 |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement The device is indicated for use in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions (length <30 mm) with a reference vessel diameter ranging from 2.75 mm to 4.25 mm and is intended to improve coronary luminal diameter. Long-term outcome (beyond 6 months) for this permanent implatn is unknown. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S017 S018 S020 S021 |